R103 :: Setting and Testing Specifications :: 1 day

The workshop addresses the regulatory requirements and the statistical tools commonly employed to help you to set and test specifications for use in your assays, processes or analytical methods. You are guided step-by-step through the tools and techniques that help to ensure your drug products meet regulatory (or in-house) standards. The workshop emphasises using a practical, data-driven approach to establish specification limits; an approach using objective criteria. During the workshop, you’ll get hands-on experience (via an easy-to-use Excel add-in, CELLULA-M) of applying the statistical principles involved in setting and testing specifications, and of managing and interpreting the associated scientific data.

Topics Covered

• Regulatory requirements
• Sampling Plans, Acceptance Criteria and Tests
• Constructing acceptance limits and specifications to meet regulatory or in-house requirements
• Evaluating the likelihood of passing a test or of meeting specification
• The importance of measuring, understanding and reducing variation

Software Tools Used*

CELLULA-M, Design Expert DX7 hands-on

Each workshop fee includes a 12 month licence to install and run a copy of CELLULA-M (option to renew the software licence in future years at £395 per annum)

Who Should Attend?

All scientists involved in setting and testing specifications for use in assays, processes or analytical methods

Recommended Preparation

• No special preparation

When and Where?                              I'm interested, keep me posted  

• Runs according to demand :: £495